A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Sponsors

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Source Kissei Pharmaceutical Co., Ltd.
Brief Summary

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.

Overall Status Recruiting
Start Date December 24, 2019
Completion Date January 2023
Primary Completion Date December 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of patients with stable platelet response 24 weeks
Secondary Outcome
Measure Time Frame
Percentage of patients with overall response 12 weeks
Duration of maintained platelet count 52 weeks
Percentage of patients with a platelet count ≥50000/μL Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years
Percentage of patients with a platelet count increase ≥20000/μL above baseline and ≥30000/μL Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: R788

Description: Oral administration

Intervention Type: Drug

Intervention Name: Placebo

Description: Oral administration

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Japanese patients

- Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent

- Patients with a platelet count averages <30000/μL during screening period. Each platelet count should not exceed 35000/μL.

- Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)

Exclusion Criteria:

- Patients with thrombocytopenia associated with other disease

- Patients with autoimmune hemolytic anemia

- Patients with poorly controlled hypertension

- Patients with a history or active coagulopathy

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Naomi Koshihara Study Director Kissei Pharmaceutical Co., Ltd.
Overall Contact

Last Name: Kissei Pharmaceutical Co., Ltd.

Phone: Email only

Email: [email protected]

Location
Facility: Status: Research Site
Location Countries

Japan

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: R788

Type: Experimental

Description: Patients are administered R788 for 24 weeks (double-blind period), followed by R788 for up to 52 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).

Label: Placebo

Type: Placebo Comparator

Description: Patients are administered Placebo for 24 weeks (double-blind period), followed by R788 for up to 28 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov